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METHOTREXATE 10 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN

Active substance(s): METHOTREXATE / METHOTREXATE / METHOTREXATE

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Common: may affect up to 1 in 10 people

5. How to store Metoject PEN







Mouth ulcers, diarrhoea.
Rash, reddening of the skin, itching.



S1797 LEAFLET Metoject 20170608
®

Metoject PEN 10 mg solution for injection in pre-filled pen

Do not store above 25°C.

®



Headache, tiredness, drowsiness.





Reduced blood cell formation with decrease in white and/or red
blood cells and/or platelets.

Keep the pre-filled pens in the outer carton in order to protect
from light.



Do not use this medicine after the expiry date stated on the
carton and pre-filled pen after EXP. The expiry date refers to
the last day of that month.

Uncommon: may affect up to 1 in 100 people


Throat inflammation.



Inflammation of the bowels, vomiting, inflammation of pancreas,
black or tarry stools, gastrointestinal ulcers and bleeding.



Increased sensitivity to light, loss of hair, increased number of
rheumatic nodules, skin ulcer, shingles, inflammation of blood
vessels, herpes-like skin rash, hives.



Onset of diabetes mellitus.



Dizziness, confusion, depression.



Decrease in serum albumin.



Decrease in the number of all blood cells and platelets.



Inflammation and ulcer of the urinary bladder or vagina,
reduced kidney function, disturbed urination.



Joint pain, muscle pain, reduction of bone mass.





Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you
no longer use. These measures will help protect the
environment.
If your pre-filled pen shows any signs of deterioration, consult
your doctor or pharmacist who will tell you what to do.

6. Contents of the pack and other information



Methotrexate 10 mg solution for injection in pre-filled pen
(methotrexate)
Your medicine is known as above names but will be referred to as
Metoject PEN throughout the following patient information leaflet.
Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.


Keep this leaflet. You may need to read it again.



If you have any further questions, ask your doctor or
pharmacist.



This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.



The active substance is methotrexate.



1 pre-filled pen with 0.2 ml solution contains 10 mg
methotrexate.


The other ingredients are sodium chloride, sodium hydroxide
and hydrochloric acid for pH adjustment and water for
injections.

If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.

3. How to use Metoject PEN

Increased skin pigmentation, acne, blue spots on the skin due
to vessel bleeding (ecchymosis, petechiae), allergic
inflammation of blood vessels.

4. Possible side effects

Metoject PEN is available in packs of 1 pre-filled pen.

6. Contents of the pack and other information

Product Licence holder

1. What Metoject PEN is and what it is used for

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.

Metoject PEN is indicated for the treatment of

Infection (incl. reactivation of inactive chronic infection), red
eyes (conjunctivitis).



Mood swings (mood alterations).



Visual disturbances.



Inflammation of the sac around the heart, accumulation of fluid
in the sac around the heart, obstruction of cardiac filling due to
fluid in the sac around the heart.



Low blood pressure.



Formation of scar tissue in the lung, shortness of breath and
bronchial asthma, accumulation of fluid in the sac around the
lung.

This product is manufactured by medac Gesellschaft für klinische
Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany.
POM

PL: 19488/1797

Stress fracture.



Electrolyte disturbances.

Leaflet revision date: 08 June 2017



Fever, wound-healing impairment.

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.



Acute toxic dilatation of the gut (toxic megacolon).



Increased pigmentation of the nails, inflammation of the cuticles
(acute paronychia), deep infection of hair follicles (furunculosis),
visible enlargement of small blood vessels.



Pain, loss of strength or sensation of numbness or tingling in
arms and legs, changes in taste (metallic taste), convulsions,
paralysis, meningism.



Impaired vision, non-inflammatory eye disorder (retinopathy).



Loss of sexual drive, impotence, male breast enlargement,
defective sperm formation (oligospermia), menstrual disorder,
vaginal discharge.



active rheumatoid arthritis in adult patients.



polyarthritic forms of severe, active juvenile idiopathic arthritis,
when the response to nonsteroidal anti-inflammatory drugs
(NSAIDs) has been inadequate,



severe recalcitrant disabling psoriasis, which is not adequately
responsive to other forms of therapy such as phototherapy,
PUVA, and retinoids, and severe psoriatic arthritis in adult
patients,



mild to moderate Crohn’s disease in adult patients when
adequate treatment with other medicines is not possible.

®

Metoject is a registered trademark of medac Gesellschaft für
klinische Spezialpräparate mbH, Germany.
®

Metex is a registered trademark of medac Gesellschaft für
klinische Spezialpräparate mbH, Germany.

Enlargement of lymphatic nodes (lymphoma).

Rheumatoid arthritis (RA) is a chronic collagen disease,
characterised by inflammation of the synovial membranes (joint
membranes). These membranes produce a fluid which acts as a
lubricant for many joints. The inflammation causes thickening of the
membrane and swelling of the joint.

The manner of handling and throwing away of the medicine and
pre-filled pen must be in accordance with local requirements.
Pregnant healthcare personnel should not handle and/or administer
Metoject PEN.
Methotrexate should not come into contact with the surface of the
skin or mucosa. In the event of contamination, the affected area
must be rinsed immediately with plenty of water.
What you need in order to administer your injection using the
Metoject PEN pre-filled pen
You need:


1 Metoject PEN pre-filled pen



1 alcohol pad

Metoject PEN pre-filled pen components:

Injection button
Handling area
Transparent control zone
Cap

a)

c) After injection

What you need to do before administering your injection
1. Wash your hands very carefully.
2. Remove the system from its packaging.
3. Check the Metoject PEN pre-filled pen before using it:
If the Metoject PEN pre-filled pen appears to be damaged do not
use it. Use another one and contact your doctor, pharmacist or
nurse.
In case a small air bubble is visible
through the transparent control zone,
this will not affect your dose nor will it
harm you.
If you are not able to see or to check the
system correctly prior to injection, ask
someone around you for assistance.

Psoriatic arthritis is a kind of arthritis with psoriatric lesions of the
skin and nails, especially at the joints of fingers and toes.
Metoject PEN modifies and slows down the progression of the
disease.
Crohn’s disease is a type of inflammatory bowel disease that may
affect any part of the gastrointestinal tract causing symptoms such
as abdominal pain, diarrhoea, vomiting or weight loss.

Increased number of certain white blood cells.

2. What you need to know before you use Metoject PEN



Nosebleed.

Do not use Metoject PEN if you



Proteins in urine.





Feeling of weakness.

are allergic to methotrexate or any of the other ingredients of
this medicine (listed in section 6).



suffer from liver or severe kidney diseases or blood diseases.



regularly drink large amounts of alcohol.



suffer from a severe infection, such as tuberculosis, HIV or
other immunodeficiency syndromes.



suffer from mouth ulcers, stomach ulcer or intestinal ulcer.

Reporting of side effects



are pregnant or breast-feeding.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.



receive vaccinations with live vaccines at the same time.

By reporting side effects you can help provide more information on
the safety of this medicine.

Talk to your doctor or pharmacist before taking Metoject PEN if you:

Warnings and precautions

With cap before injection

b) After cap removal before
injection

Psoriasis is a common chronic skin disease, characterised by red
patches covered by thick, dry, silvery, adherent scales.

Not known: frequency cannot be estimated from the available data

Subcutaneous application of methotrexate is locally well tolerated.
Only mild local skin reactions (such as burning sensations,
erythema, swelling, discolouration, severe itching, pain) were
observed, decreasing during therapy.

Additional information

Juvenile arthritis concerns children and adolescents less than 16
years. Polyarthritic forms are indicated if 5 or more joints are
affected within the first 6 months of the disease.

S1797 LEAFLET Metoject 20170608



 Always use the injection technique advised by your doctor,
pharmacist or nurse.

5. How to store Metoject PEN

Manufacturer



Very rare: may affect up to 1 in 10,000 people

 Carefully read the instructions below before starting your
injection.

2. What you need to know before you use Metoject PEN
One pre-filled pen containing a clear, yellow-brown pre-filled glass
syringe with chlorobutyl rubber plunger stopper and embedded
injection needle. Alcohol pads are also included in the package.



Recommendations

1. What Metoject PEN is and what it is used for

What Metoject PEN looks like and contents of the pack

Decreased number of anti-bodies in the blood.

Instructions for use

What is in this leaflet

Inflammation of gum tissue.





Metex PEN 10 mg solution for injection in pre-filled pen

What Metoject PEN contains

Rare: may affect up to 1 in 1,000 people


Package leaflet: Information for the user

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

4. Set the Metoject PEN pre-filled pen on
a clean flat surface (such as a table).
Where you should administer the injection
The most appropriate zones for your injection are:


upper thighs,



abdomen except around the navel.



If someone around you administers the injection for you, the
person may also use the top of the zone at the back of the arm,
just below the shoulder.


Change the injection area with each
injection. This will minimize any
reactions at the injection site.



Never inject into areas where the
skin is tender, bruised, red or hard
or where you have scars or stretch
marks. If you have psoriasis, you
should not try to inject directly into
any raised, thick, red or scaly skin
patches or lesions.

How to prepare the injection
5. Clean your skin in the chosen
injection zone using the enclosed
alcohol pad.



are elderly or if you feel generally unwell and weak.



have problems with the way your liver works.

6. Hold the Metoject PEN pre-filled
pen with one hand in the handling
area.



suffer from dehydration (water loss).



Do not remove the cap before you
are ready to administer the
injection.

7.

Use your other hand to pull the cap
straight off. The small needle shield
comes off with the cap automatically.
If not, use another pen and contact
your doctor, pharmacist or nurse.



Do not press the button until you are
ready to inject.



If you are unable to remove the cap,
ask someone around you for
assistance.

Note: Once you have removed the cap, perform your injection
without delay.
8.



With your free hand, build a skin
fold by gently squeezing the area
of the cleaned skin at the injection
site.
The fold must be held pinched
until the Metoject PEN pre-filled
pen is removed from the skin after
the injection.

9. Position the uncapped transparent
end of Metoject PEN pre-filled pen
perpendicular to the fold of skin.
10. Without pressing the button, push
the Metoject PEN pre-filled pen
firmly onto your skin in order to
unlock the button.


If you are unable to push the
Metoject PEN pre-filled pen to the
stop-point, ask someone around you
for assistance.

How to administer the injection:
11. While holding the Metoject PEN
pre-filled pen firmly against the
skin, now press the button with
your thumb.
12. You will hear a click which
indicates the start of the injection.
Keep holding the pen against the
raised skin until all of the medicine
is injected. This can take up to 5
seconds.

Recommended follow-up examinations and safety measures:

Pregnancy, breast-feeding and fertility

4. Possible side effects

Even when Metoject PEN is administered in low doses, severe side
effects can occur. In order to detect them in time, check-ups and
laboratory tests have to be carried out by your doctor.

If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Before therapy:
Before starting the treatment, blood samples will be taken in order
to check that you have enough blood cells, tests to check your liver
function, serum albumin (a protein in the blood) and kidney function.
Your doctor will also check if you suffer from tuberculosis (infectious
disease in combination with little nodules in the affected tissue) and
a chest X-ray will be taken.
During therapy:
You will have the following tests at least once a month during the
first six months and at least every three months thereafter:

If the injection is not triggered, release the button, make sure that
the Metoject PEN pre-filled pen is pressed firmly against the skin
and push hard on the button.
If you have troubles with your hearing, count 5 seconds from the
moment you have pressed the button and then lift the Metoject PEN
pre-filled pen from the injection site.
13. Remove the Metoject PEN prefilled pen from the injection site,
perpendicular to the skin (pull up).
14. The protective shield automatically
moves into place over the needle.
The protective shield is then
locked and the needle is protected.
15. In case of a slight bleeding use a
plaster.
Before throwing away the Metoject PEN pre-filled pen, check
visually that there is no liquid left in the pen, at the bottom of the
transparent control zone. If there is liquid left in the pen, not all of
the medicine has been injected correctly and you should consult
your doctor.
Note
To avoid any injury, never insert your fingers in the opening of
the protective tube covering the needle. Do not destroy the pen.
Whom should you contact in case of need
 For any problem or question, contact your doctor, pharmacist or
nurse.
 If you or someone around you is injured by the needle, consult
your doctor immediately and throw away the Metoject PEN prefilled pen.

Leaflet revision date: 08 June 2017

As methotrexate can be genotoxic, all women who wish to become
pregnant are advised to consult a genetic counselling centre, if
possible, already prior to therapy. Men should seek advice about
the possibility of sperm preservation before starting therapy.
Stop breast-feeding prior to and during treatment with Metoject
PEN.

Examination of the mouth and throat for changes of the
mucosa.



Blood tests.

Driving and using machines



Check of liver function.



Check of kidney function.



Check of respiratory system and if necessary lung function test.

Treatment with Metoject PEN may cause adverse reactions
affecting the central nervous system, such as tiredness and
dizziness. Thus the ability to drive a vehicle and/or to operate
machines may, in certain cases, be compromised. If you feel tired
or drowsy do not drive or use machines.

Methotrexate may affect your immune system and vaccination
results. It may also affect the result of immunological tests.
Inactive, chronic infections (such as herpes zoster [shingles],
tuberculosis, hepatitis B or C) may flare up. During therapy with
Metoject PEN you must not be vaccinated with live vaccines.
Radiation-induced dermatitis and sun-burn can reappear under
methotrexate therapy (recall-reaction). Psoriatic lesions can
exacerbate during UV-irradiation and simultaneous administration
of methotrexate.
Enlarged lymph nodes (lymphoma) may occur and if this is the
case, therapy must be stopped.
Diarrhoea can be a possible side effect of Metoject PEN and
requires an interruption of therapy. If you suffer from diarrhoea
please speak to your doctor.
Certain brain disorders (encephalopathy/leukoencephalopathy)
have been reported in cancer patients receiving methotrexate. Such
side effects cannot be excluded when methotrexate is used to treat
other diseases.

The frequency as well as the degree of severity of the side effects
depends on the dosage level and the frequency of administration.
As severe side effects may occur even at low dosage, it is important
that you are monitored regularly by your doctor. Your doctor will do
tests to check for abnormalities developing in the blood (such as
low white blood cells, low platelets, lymphoma) and changes in the
kidneys and the liver.
Tell your doctor immediately if you experience any of the
following symptoms, as these may indicate a serious, potentially
life-threatening side effect, which require urgent specific treatment:


persistent dry, non-productive cough, shortness of breath
and fever; these may be signs of an inflammation of the lungs
[common]



symptoms of liver damage such as yellowing of the skin
and whites of the eyes; methotrexate can cause chronic liver
damage (liver cirrhosis), formation of scar tissue in the liver
(liver fibrosis), fatty degeneration of the liver [all uncommon],
inflammation of the liver (acute hepatitis) [rare] and liver failure
[very rare]



allergy symptoms such as skin rash including red itchy
skin, swelling of the hands, feet, ankles, face, lips, mouth
or throat (which may cause difficulty in swallowing or
breathing) and feeling you are going to faint; these may be
signs of severe allergic reactions or an anaphylactic shock
[rare]



symptoms of kidney damage such as swelling of the
hands, ankles or feet or changes in frequency of urination
or decrease (oliguria) or absence of urine (anuria); these
may be signs of kidney failure [rare]



symptoms of infections, e.g. fever, chills, achiness, sore
throat; methotrexate can make you more susceptible to
infections. Severe infections like a certain type of pneumonia
(Pneumocystis carinii pneumonia) or blood poisoning (sepsis)
may occur [rare]



symptoms such as weakness of one side of the body
(stroke) or pain, swelling, redness and unusual warmth in
one of your legs (deep vein thrombosis); this may happen
when a dislodged blood clot causes blockage of a blood
vessel (thromboembolic event) [rare]



fever and serious deterioration of your general condition,
or sudden fever accompanied by a sore throat or mouth, or
urinary problems; methotrexate can cause a sharp fall in
certain white blood cells (agranulocytosis) and severe bone
marrow suppression [very rare]



unexpected bleeding, e.g. bleeding gums, blood in the
urine, vomiting blood or bruising, these can be signs of a
severely reduced number of blood platelets caused by severe
courses of bone marrow depression [very rare]



symptoms such as severe headache often in combination
with fever, neck stiffness, feeling sick, vomiting,
disorientation and sensitivity to light may indicate an
inflammation of the membranes of the brain (acute aseptic
meningitis) [very rare]



certain brain disorders (encephalopathy/ leukoencephalopathy)
have been reported in cancer patients receiving methotrexate.
Such side effects cannot be excluded when methotrexate
therapy is used to treat other diseases. Signs of this kind of
brain disorders may be altered mental state, movement
disorders (ataxia), visual disturbances or disturbances of
memory [not known]



severe skin rash or blistering of the skin (this can also
affect your mouth, eyes and genitals); these may be signs of
conditions called Stevens Johnson syndrome or burned skin
syndrome (toxic epidermal necrolysis/Lyell’s syndrome) [very
rare]

Metoject PEN contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per
dose; i.e. essentially “sodium-free”.
3. How to use Metoject PEN
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Your doctor decides on the dose, which is adjusted individually to
you. Usually it takes 4 – 8 weeks before there is any effect of the
treatment.
Metoject PEN is administered subcutaneously (under the skin) by or
under the supervision of a physician or healthcare staff as an
injection once a week only. Together with your doctor you decide
on a suitable weekday each week on which you receive your
injection.
Use in children and adolescents

Other medicines and Metoject PEN
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. Please note that this also
applies to medicines that you will take in the future.
The effect of the treatment may be affected if Metoject PEN is
administered at the same time as certain other medicines:




Antibiotics such as: tetracyclines, chloramphenicol, nonabsorbable broad-spectrum antibiotics, penicillines,
glycopeptides, sulphonamides, ciprofloxacin and cefalotin
(medicines to prevent/fight certain infections).
Non-steroidal anti-inflammatory drugs or salicylates
(medicines against pain and/or inflammation such as
acetylsalicylic acid, diclofenac and ibuprofen or pyrazole).



Probenecid (medicine against gout).



Weak organic acids like loop diuretics (“water tablets”).



Medicines, which may have adverse effects on the bone
marrow, such as trimethoprim-sulphamethoxazole (an
antibiotic) and pyrimethamine.



Other medicines used to treat rheumatoid arthritis such as
leflunomide, sulphasalazine and azathioprine.



Mercaptopurine (a cytostatic agent).



Retinoids (medicine against psoriasis and other dermatological
diseases).



Theophylline (medicine against bronchial asthma and other
lung diseases).



Some medicines against stomach trouble such as omeprazole
and pantoprazole.



Hypoglycaemics (medicines that are used to lower the blood
sugar).

Vitamins containing folic acid may impair the effect of your
treatment and should only be taken when advised by your doctor.
Vaccination with live vaccine must be avoided.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

In women of child-bearing age, any existing pregnancy must be
excluded with certainty by taking appropriate measures, such as
pregnancy test, prior to therapy.



Note:
Do not remove the Metoject PEN pre-filled pen from the skin before
the end of the injection to avoid incomplete injection.

Do not use Metoject PEN during pregnancy. There is a risk of harm
to the foetus and miscarriage. Men and women should use an
effective method of birth control during treatment and during a
further six months after treatment with Metoject PEN has been
discontinued.

Metoject PEN with food, drink and alcohol
Alcohol as well as large amounts of coffee, caffeine-containing soft
drinks and black tea should be avoided during treatment with
Metoject PEN.

The doctor decides on the appropriate dose in children and
adolescents with polyarthritic forms of juvenile idiopathic arthritis.
Metoject PEN is not recommended in children less than 3
years of age due to insufficient experience in this age group.
Method and duration of administration
Metoject PEN is injected once weekly!
The duration of the treatment is determined by the treating
physician. Treatment of rheumatoid arthritis, juvenile idiopathic
arthritis, psoriasis vulgaris, psoriatic arthritis and Crohn’s disease
with Metoject PEN is a long-term treatment.
At the start of your therapy, Metoject PEN will be injected by
medical staff. However, your doctor may decide that you are able to
learn how to inject Metoject PEN under the skin yourself. You will
then receive appropriate training. Under no circumstances
should you try to inject Metoject PEN yourself before you have
received such training.
You can also find guidance on how to use Metoject PEN in the
section “Instructions for use” at the end of this leaflet.
Please note that all of the contents have to be used.
The manner of handling and throwing away of the medicine and
pre-filled pen must be in accordance with local requirements.
Pregnant health care personnel should not handle and/or
administer Metoject PEN.
Methotrexate should not come into contact with the surface of the
skin or mucosa. In the event of contamination, the affected area
must be rinsed immediately with plenty of water.

In the following, please find the other side effects that may occur:


Inflammation of the mouth lining, indigestion, feeling sick, loss
of appetite, abdominal pain.

If you use more Metoject PEN than you should



Abnormal liver function tests (ASAT, ALAT, bilirubin, alkaline
phosphatase).

If you use more Metoject PEN than you should, talk to your doctor
immediately.
If you forget to use Metoject PEN
Do not take a double dose to make up for a forgotten dose.
If you stop using Metoject PEN
If you stop using Metoject PEN, talk to your doctor immediately.
If you have the impression that the effect of Metoject PEN is too
strong or too weak, talk to your doctor or pharmacist.

Very common: may affect more than 1 in 10 people

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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